Expired Study
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Houston, Texas 77030


Purpose:

The Niris™ OCT Imaging System is a device used in the operating room together with cystoscopy in order to be able to see the condition of the bladder wall. The current implementation of the fiber optic based OCT probe has a 2.7mm (OD) which easily integrates with standard cystoscopy equipment. It builds on the basic skills of conventional cystoscopy, making it straight-forward to learn and simple to use. Imaging data are captured quickly with a 1.5 second scan time per image. The data acquisition module is smaller than a desktop computer and permits real-time capture of data in a digital format. OCT offers a rapid, minimally-invasive adjunct to white light cystoscopy that may aid in diagnosis and staging of bladder cancer. The image it produces has been proven to show tumors that go deeper than first thought and to show tumors in the earliest stages. The ability to find bladder tumors at the earliest stage and to remove and treat the bladder to prevent recurrence has been proven to be the key to long-term cancer control.


Study summary:

Bladder cancer is the fourth most common cancer in men and the eighth most common in women with approximately 60,000 new cases diagnosed every year. The highest occurrence of bladder cancer is found in industrialized countries such as the United States, Canada, Denmark, Italy and Spain. The incidence is three to four times higher in men compared with women, and the incidence rises with age. Among white men, the annual incidence after the age of 65 is approximately two per 1000 people and the lifetime chance of developing bladder cancer is over 3%. The majority of patients have non-muscle invasive bladder cancer (cancer that has not spread into the bladder muscle) which can be controlled, but survival depends upon early detection of the cancer. In the 20 years following diagnosis, there is a recurrence rate (the cancer returns after treatment) of 50 to 75%, a progression rate (cancer recurs and is now invasive) of 10 to 40% and a death rate of 10 to 30%. Optical coherence tomography (OCT) was first used to image human tissue in 1991 and has been developed for clinical applications since that time. OCT employs light (instead of sound waves) to obtain images in a manner analogous to B-mode ultrasonography performing real-time, 10-20 micron scale imaging, nearing the resolution of histopathology. OCT performs two- and three-dimensional imaging in biological tissues by directing harmless near infrared light onto the tissue and measuring the reflected or backscattered intensity of light as a function of depth[1]. Direct comparisons have been performed between OCT and the current clinical technology with the highest resolution, high frequency ultrasound. OCT demonstrated superior performance both quantitatively and qualitatively. The potential clinical use of OCT in the bladder is closely related to cystoscopic imaging with white light. The complementary use of OCT with standard cystoscopy allows acquisition of real-time images of regions of interest at a depth of up to 2mm and a spatial resolution of ~10-20 um. Furthermore, OCT technology is fiber-optic based, which allows its relatively straightforward integration with small catheters and cystoscopes. OCT imaging is performed in real-time making it an attractive technology for implementation as a single episode point-of-care diagnostic, monitoring and surgical-guiding tool. Finally, as an optical imaging technology, OCT can be combined with other optical modalities such as absorption and polarization spectroscopy.


Criteria:

Inclusion Criteria: 1. Patients demonstrating one or more papillary tumors of the urinary bladder amenable to complete resection (Clinical stage Ta or T1) and not requiring a cystectomy, as identified by outpatient cystoscopy 2. Patients with a positive cytology or FISH with or without visible tumor Exclusion Criteria: 1. Tumor at Bladder neck 2. Under 21 years of age 3. Pregnancy or breast feeding


Study is Available At:


Original ID:

H#21830 Imalux


NCT ID:

NCT00831558


Secondary ID:

Imalux Corp. v.12-31-07


Study Acronym:

OCT


Brief Title:

Bladder Cancer Imaging Study-OCT Imaging to Stage Bladder Tumors


Official Title:

Optical Coherence Tomography as an Adjunct to White Light Cystoscopy for Intravesical Real Time Imaging and Staging of Bladder Cancer


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Baylor College of Medicine


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Case-Only, Time Perspective:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

68


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Seth P. Lerner, M.D.
Principal Investigator
BCM

Study Dates

Start Date:March 2008
Completion Date:March 2014
Completion Type:Anticipated
Primary Completion Date:December 2013
Primary Completion Type:Anticipated
Verification Date:July 2013
Last Changed Date:July 22, 2013
First Received Date:January 27, 2009

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Correlate cystoscopic stage and grade,surgeon's interpretation of OCT images with histopathologic stage and grade
Time Frame:Upon receipt of data
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Assessment of accuracy and positive predictive value of OCT for determining tumor stage correlated by histopathology
Time Frame:Upon receipt of data
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Patients
Description:Patients demonstrating one or more papillary tumors of the urinary bladder amenable to complete resection (Clinical stage Ta or T1) and not requiring a cystectomy, as identified by outpatient cystoscopy Patients with a positive cytology or FISH with or without visible tumor

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Baylor College of Medicine

Samples and Retentions

Study Population: Subjects with a bladder tumor to be rescted in the operating room
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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